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VICH process

New Zealand and Australia have been active observer members of the VICH process (the International Co-operation on Harmonisation of Technical Requirements for the Registration of Veterinary Medicinal Products) since it was formed in the mid 1990s.

The second VICH conference is taking place in Tokyo from 9 - 11 October. At that stage Debbie Morris, ACVM Group Director, will take over as the Government representative on the steering group for Australia and New Zealand. Brian Pidford (ACVM Group Programme Manager Verification) and John Reeve (Programme Manager Toxicology and Residues) have both been experts representing New Zealand and Australia on a number of the working groups.

Dr Bill Jolly, who is now the New Zealand veterinary counsellor in Brussels, has been invited to give one of the closing addresses to the conference on 'VICH – the way forward'.

The VICH process has delivered a number of harmonised guidelines that have already been endorsed by AVMAC and are incorporated into the ACVM standards and guidelines wherever appropriate. All of these are available on the NZFSA website ( http://www.nzfsa.govt.nz/policy-law/vich/index.htm ), along with a more  detailed explanation of the VICH membership and process.

The following VICH guidelines in development have reached step 4 – the step where they undergo consultation prior to being signed off and implemented. They are available on the website. Because Agcarm and ARPPA as industry groups are part of the VICH process, comments can be made through them or directly to the ACVM Group.

• Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs), VICH GL24 (Pharmacovigilance: AERs) June 2000 For consultation at step 4
• Pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance, GL27 (Antimicrobial resistance: pre-approval) For a 6-month public consultation at step 4 - Draft 1
• Studies to evaluate the safety of residues of veterinary drug in human food: carcinogenicity testing, GL28 (Safety carcinogenicity testing) For a 6-month public consultation at step 4 - Draft 1
• Pharmacovigilance of veterinary medicinal products: management of Periodic Summary Update Reports (PSUs), GL29 (Pharmacovigilance: PSUs) For a 6-month public consultation at step 4 - Draft 1
• Pharmacovigilance of veterinary medicinal products: Controlled list of terms, GL30 (Pharmacovigilance: controlled terms) For a 6-month public consultation at step 4 - Draft 1
• Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat dose toxicity testing, VICH GL31 (Safety Repeat dose) April 2002 For a 5-month public consultation at step 4 - Draft 1
• Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing, VICH GL32 (Safety Developmental toxicity) April 2002 For a 5-month public consultation at step 4 - Draft 1
• Studies to evaluate the safety of veterinary drug residues in human food: General approach to testing, VICH GL33 (Safety General Approach) April 2002 For a 5-month public consultation at step 4 - Draft 1
• Testing for the detection of Mycoplasma contamination, VICH GL34 (Biologicals: Mycoplasma) April 2002 For a 12-month public consultation at step 3 - Draft 1

ACVM Group staff member resignation

Leonie Thomson, Advisor (Operations), has resigned from the ACVM Group to pursue opportunities in the United Kingdom.

Leonie was with the ACVM Group for more than three years and takes a wealth of knowledge and enthusiasm with her. Leonie will be sorely missed for her bubbly personality and the special spark she brought to the Group.

Leonie will be replaced by Deborah Alexander, who previously held the position of Coordinator (Operations) for the ACVM Group. Deborah has been with the Group for 18 months and is looking forward to the challenges of her new position.